A fourth-quarter earnings miss and the uncertainty around an upcoming FDA advisory panel meeting on breast implants sent Sientra (NSDQ:SIEN) shares down precipitously today. The Santa Barbara, Calif.-based medical aesthetics company’s losses widened 38.1% to -$24.6 million, or 86¢ per share, on sales growth of 71.9% to $19.0 million for the three months ended Dec. […]
Cosmetic/Aesthetic
Almirall deals ThermiGen medtech assets to Celling Biosciences
ThermiGen owner Almirall said today that it sold its ThermiGen assets to Celling Biosciences for an undisclosed amount. The deal is expected to close on March 29, Barcelona-based Almirall said. Through the deal, Austin, Texas-based Celling Biosciences will take control of Thermi and its 94 Dallas-based employees as well as its more than 2,000 users, […]
FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. […]
Clarify Medical wins CMS reimbursement for phototherapy psoriasis treatment
Clarify Medical said today that it won reimbursement coverage through the U.S. Centers for Medicare & Medicaid Services for treatments with its Clarify Home light therapy system for treating psoriasis, effective immediately. The new decision from CMS falls under its National Coverage Determination for the treatment of psoriasis, which includes narrowband ultraviolet B phototherapy, San […]
Cutera parts ways with CEO after missed 2018 prelims
Cutera (NSDQ:CUTR) this week parted ways with president & CEO James Reinstein after the aesthetic device maker missed expectations for its 2018 top line, naming COO Jason Richey as interim chief executive. Brisbane, Calif.-based Cutera said Jan. 7 that it expects to post sales of $161 million to $163 million for last year, short of the consensus […]
Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery
A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report. The patient, Wendy Knecht, underwent […]
Bovie Medical seeks new FDA indications for J-Plasma, Renuvion tech
Bovie Medical (NYSE:BVX) said today it submitted a 510(k) premarket notification to the FDA seeking expanded clearance for its J-Plasma and Renuvion technology. The Clearwater, Fla.-based company, which is looking to rebrand under the new moniker Apyx Medical Corporation beginning next year, said it is looking to clear the system for use in dermal resurfacing procedures. […]
Kleresca cleared to enter Australian, Canadian markets
Dermatological device developer Kleresca said today that it has been certified by the Medical Device Single Audit Program (MDSAP), boosting its plan to enter new markets. The audit gave Kleresca regulatory clearance to enter the medical device markets of Australia and Canada. With minor additional audits and approvals, the certification will also apply to Brazil, Japan, and the United States, […]
Strata Skin Sciences adds license for excimer laser vitiligo treatment
Strata Skin Sciences (NSDQ:SSKN) said it has reached an agreement with an “internationally acclaimed health institution” giving Strata an exclusive license to treat vitiligo using its Xtrac excimer laser. In a novel treatment for vitiligo, the excimer laser incrementally increases the light emitted in the UVB range to restore pigmentation to skin areas affected with […]
Report: FDA-reported breast implant injuries kept hidden by summary reporting
The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser. Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly […]
Syneron Candela updates on patent infringement cases
Syneron Candela today updated on a number of patent infringement suits, including a large number in defense of its Profound radiofrequency-based microneedling product. The Wayland, Mass-based company said that in April, it filed complaints against 18 manufacturers and distributors of fractional RF micro-needle dermatological treatment systems in both the U.S. Int’l Trade Commission and Federal District […]